NL-OMON33221已完成2 期
An Exploratory Study Investigating the Use of the Lutonix Paclitaxel-Coated Balloon in Conjunction with Bare Metal Stenting in Patients with De Novo Coronary Lesions - The Lutonix De Novo Pilot Study
utonix0 个研究点目标入组 18 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Documented stable angina pectoris CCSC 1-4, unstable angina pectoris with documented ischemia (Braunwald 1-II) or documented silent ischemia
- •Target lesion is a de novo lesion in a native coronary artery vessel
- •Initial stenosis is >50% and <100% by visual estimate or QCA
- •Target lesion is <18 mm in lenght and can be treated in its entirety by no more than 1 single Lutonix Catheter balloon and 1 single BMS
排除标准
- •History of Stroke within past 6 months
- •History of MI or thrombolysis within 72 hours of randomization
- •Prior vascular brachytherapy
- •Angiographic evidece of thrombus or dissection within the target vessel
研究者
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